[Janssen] Senior Medical Safety Specialist

Description

 

A global leader in health and personal care, with over 125,000 employees in over 275 companies in 60 countries. We work with partners in healthcare to touch the lives of more than a billion people every day throughout the world. Johnson & Johnson companies market leading products and services in three business segments: Consumer, Pharmaceuticals, and Medical Devices.

“By caring, one person at a time, we aspire to help billions of people live longer, healthier, happier lives.”

We have a new and exciting opportunity to hire a Medical Safety Specialist for our Pharmacovigilance here at Taipei, Taiwan office.

 

Job Purpose and Scope:

Support the Medical Safety – Associate Manager to fulfil the responsibility for the coordination and execution of all Medical Safety (MS) activities across the Pharmaceutical and Consumer sectors. Act as one of the Local Operating Company (LOC)’s and assigned territories’ (as applicable) contact point for Medical Safety matters with Global Medical Organisation (GMO), Office of Consumer Medical Safety (OCMS), Global Medical Safety (GMS). Support PV team and LOC stakeholders to meet all global and local MS responsibilities.

 

Core Job Responsibilities:

Medical Safety Specialist - Taiwan:

Support the oversight of MS activities –

•               Support oversight of the assigned cross sector product portfolio, and link with local management and key stakeholders

•               Support to maintain oversight of all required MS regulatory reporting compliance in a timely manner e.g RMPs, aggregate reports.

•               Advise the business on the MS impact of local organized data collection programs, post marketing programs, RWE studies etc.

•               Escalate compliance issues in a timely manner to Line Manager and North Asia Cross Sector Safety Area Lead to ensure appropriate mitigation is implemented.

•               Monitor and forecast MS workload to identify, mitigate and escalate potential MS resource and non-compliance issues.

•         Support and lead process improvements to optimize MS activities.

•         Work collaboratively with regional affiliates to ensure consistency of approach across groups.

•         Build and maintain effective business relationships across the LOC.

•         Provide high quality and consistent input to development of local safety initiatives and programs.

•               Support the maintenance of  an environment of continuous improvement within the MS team and contribute to continuous improvement initiatives across the region and globally with GMO, OCMS and GMS.

Key Medical Safety Activities:

•               Support signal detection – ensure LOC complies with any local HA signal-detection requirements, collaborate with regional and global colleagues to signal detection activities and communications.

•               Support intensive monitoring programs including Compassionate Use Program, Patient Access Program, Registries, Post-Marketing Studies – involvement with key stakeholders to ensure the programs meet local, regional or global requirements from a compliance and strategic safety perspective.

•               Monitor any MS service providers to ensure PV and MS obligations are being fulfilled.

 

Risk Management:

•               Have an appropriate system of and Risk Management in place in order to assure appropriate oversight for products within its responsibility

•         Review and complete country specific Annex as required according to local requirements, if applicable

•               Collaborate with Medical Affairs and Regulatory Affairs team to ensure that RMP activities are completed on a timely manner

•               Ensure implementation and tracking of RMP activities are in place including documentation of completed activities

•         Review all risk management plans and PSURs to obtain information on the risk/benefit profile of products

•               Monitor the risk/benefit profile of local products and communicate changes or safety issue/concerns to the APAC Cross Sector Safety Team Lead, and the QPPV (for products marketed in the EMEA) for evaluation.

•               Provide MS input in pre-authorisation phase/submission-planning phase of product lifecycle to guide appropriate planning and management of RMP-related activities.